Hi Sheri,
Thank you, as always, for your comments. Vaccine compensation laws are very complicated, and I think purposefully so. I didn’t go into extensive detail in my article (I was “nutshelling” the liability issue so readers wouldn’t miss the bigger picture), but this is my understanding:
I don’t think manufacturer liability is date-specific.
There are actually two different programs that address manufacturer liability for vaccines: (1) the Countermeasures Injury Compensation Program (CICP), authorized by Public Readiness and Emergency Preparedness Act (PREP Act), for EUA vaccines and (2) the National Vaccine Injury Compensation Program (VICP) for childhood vaccines (https://www.hrsa.gov/vaccine-compensation/covered-vaccines/index.html). Damages for both programs are paid out of government funded “pots.”
Further, my understanding is that the only way an injured party can sue under CICP is if they can prove willful misconduct and the U.S. government brings an enforcement action against the party for willful misconduct. That’s a pretty high bar. Cases rarely succeed, and the government has been very stingy about awarding damages.
However, the protections above do not apply under many state product liability laws if the manufacturer (or its intermediaries) does not give “proper warning” to consumers:
“The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk.
The qualification ‘’proper warning is given’’ is critically important and a manufacturer will be liable if he markets a drug or vaccine with known risks and fails to warn of them, and it can be shown that the recipient would not have taken the drug or vaccine had he known of the risks.
…
The law summarized here appears to lead to the conclusion that a vaccine manufacturer need not fear liability from injuries resulting from the administration of the vaccine if (1) the vaccine is correctly manufactured in accordance with regulatory standards and prudent manufacturing practices and (2) the manufacturer has taken reasonable steps to ensure that the recipient of the vaccine will be warned of possible side effects.”
https://www.ncbi.nlm.nih.gov/books/NBK216813/
This is where I think Pfizer could get into trouble, and I think they know it. Pfizer is putting an FDA “approved” product into the stream of commerce for optics purposes (even though the product is still under lengthy clinical trials for “known serious risks”), but they are legally distributing it under an EUA that limits their liability under the CICP and is not subject to product liability laws.
I know it’s somewhat confusing, but I hope this makes sense. Thanks again for highlighting this issue for others.
